Greenbrae Dermatology Amc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, examination of laboratory reagent materials and solutions, and interviews with the laboratory assistant (LA); it was determined that the laboratory failed in using reagents when they have exceeded their expiration date. The findings include: 1. Based on the surveyor's observations during the laboratory tour, multiple reagent materials and solutions were found to have exceeded its expiration date and were continuously used for patient testing. Reagent / Solution Lot # Expiration date a. 1% Toluidine Blue 1319 11-2013 b. 10% KOH 9301 10-25-2021 c. 10% KOH 1824011 8-28-2019 d. Chlorazol Black E K213P1 3-31-2022 e. Chlorazol Black E K18API 10-31-2019 2. The LA affirmed by interview on February 20, 2025 at approximately 10:35 a.m. that the laboratory used the reagent materials and solutions listed on #1 beyond its expiration date for patient testing. 3. Based on the testing declaration submitted at the time of survey, the laboratory tested and reported approximately 9 tests samples for Mycology and Parasitology during the time when reagent materials and solutions used were past its expiration date. Thus, the quality and accuracy of patient results cannot be assured. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the laboratory's preventive maintenance (PM) documentation, five (5) randomly selected patient test records, and an interview with the office manager (OM), it was determined that the laboratory failed to ensure performed tests and function checks were documented properly prior to patient testing. The findings include: 1. Based on the surveyor's review of 5 randomly selected patient test records, no

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of fungal culture and vials of expired DTM (Dermatophyte Test Medium), review of test records, and interview with Testing Person-1, it was determined that the laboratory used DTM past their expiration date. Findings included: a. A fungal culture dated 2/15/19 was inoculated onto DTM lot # D1161- 1215, expiration date 12/17/2017. b. Laboratory test records revealed only DTM expired 12/17/17 were available for use throughout 2018 to 2/25/19, date of inspection. c. Testing Person-1 affirmed (2/25/19 at 1:00pm) the aforementioned observations. d. The reliability and quality of fungal cultures results could not be assured when expired media was used. Based on review of laboratory records, the laboratory performed more than 5 fungal cultures in 2018. . . D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on observation of DTM, review of the log book for fungal cultures, the lack of QC records, and interview with Testing Person-1, the laboratory failed to check each lot number of DTM for its ability to support growth of dermatophytes and produce appropriate biochemical response. Findings included: a. DTM lot # D1161-1251 was available for use and had been inoculated for a fungal culture on 2/15/19. b. The laboratory was unable to provide for review QC records checking each lot number for its ability to support growth of dermatophytes in 2017 to 2019. c. Testing Person-1 affirmed (2/25/19 at 1:00pm) the aforementioned lack of QC for each lot # of DTM used. d. The reliability and quality of negative fungal cultures could not be assured when the DTM had not been checked for it's ability to support growth of dermatophytes. -- 2 of 2 --